| CTRI Number |
CTRI/2025/08/092947 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani
Other (Specify) [Local application of Rogan-e- qust ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
a clinical study to evaluate the efficacy and safety of soft and prolong massage with Qust oil in knee osteoarthritis |
|
Scientific Title of Study
|
A randomized parallel group open label standard controlled clinical study to evaluate the therapeutic efficacy and safety of Dalk layyin kathir with Ravghan i Qust in Knee Osteoarthritis (Waja al rukba) |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohd Sameer |
| Designation |
MD Scholar |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar bypass road Bhopal
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar bypass road Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7351893975 |
| Fax |
|
| Email |
sameer.07860786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ABDUL REHMAN MI |
| Designation |
lecturer |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital AYUSH campus Kolar bypass road Bhopal
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital AYUSH Campus Kolar bypass road Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7879794103 |
| Fax |
|
| Email |
drarehman80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohd Sameer |
| Designation |
MD Scholar |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar bypass road Bhopal
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar bypass road Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7351893975 |
| Fax |
|
| Email |
sameer.07860786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Bhopal Madhya Pradesh Medical Science University Jabalpur 482003 Madhya Pradesh India |
|
|
Primary Sponsor
|
| Name |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar bypass road Bhopal
Madhya Pradesh
462003
|
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohd Sameer |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
OPD 7 Department of Ilaj bit Tadbeer ground floor Male therapy unit ground floor Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital
Bhopal
Bhopal
MADHYA PRADESH |
7351893975
sameer.07860786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dalk Layyin Kathir |
Before the procedure, the patient is made to lie in a supine position with the knee extended. After that, the hairs of the affected knee will be shaved with the help of a sterilized Razor and then we will clean the joint with water and dry it with cotton after that a superficial gentle rubbing with light pressure and slow movement from the distal to the proximal will be started with 20 ml of oil on each knee joint, once a day for 15 minutes for a period of 28 days (14 sittings) that will be on the 0th 3rd 5th 7th 9th 11th 13th 15th 17th 19th 21st 23rd 25th 28th day. |
| Comparator Agent |
Diclofenac Gel |
In this group, Patients will be instructed to apply 4 gm. of the Diclofenac gel to the front of the affected knee at bedtime for a period of 28 days. The Patient will be instructed to rub in for not more than 1 minute until the gel vanishes, paying specific attention to the medial (internal) area. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Unilateral or Bilateral KOA
2.Diagnosed patients of KOA based on clinical and or radiographic criteria such as those established by the American College of Rheumatology (ACR)
3.Patient classified as grade 2 or 3 for KOA according to the Kellgren Lawrence Grading System
4.Radiographic Evidence presence of characteristic changes on knee X-rays such as joint space narrowing, osteophytes, and subchondral bone changes 5.Symptoms persisting for a specified period often at least six months 6.At screening, patients on any analgesic anti-inflammatory medication shall be screened on the Visual Analogue Scale (VAS) of pain after walking on a 50 ft. flat surface of more than30 mm but less than 90 mm using a 100 mm scale. If patients taking no analgesic anti-inflammatory medication in the previous 3 days from screening then they should have a VAS pain score after walking on a 50 ft. flat surface of more than 40 mm but less than 90 mm If bilateral knee pain is present the more painful knee will be selected 7.Patient who can perform the 50 ft walk test without the support of crutches or other assistive devices 8.Patients who are willing to discontinue all NSAIDs or other analgesic medication taken for any other condition, including their knee pain
9.Patient fulfilling the inclusion criteria and agree to follow the protocol
10.Willingness and ability to comply with study requirements including attending study visits and completing assessments |
|
| ExclusionCriteria |
| Details |
Pregnant & lactating women
Patients participating in an experimental device, study or any clinical trial within the previous 30 days before screening
Other types of arthritis (Rheumatoid Arthritis, Gout) etc
Osteoporosis, Venous disorders.
Any knee surgery in the previous three months.
Use of oral corticosteroids within the past 3 weeks
Intra articular depo corticosteroids within the previous 3 months or intra articular hyaluronate within the previous 3 months
Arthroscopy of the knee within the previous year.
Patient with Kellgren Lawrence Grade 0, 1 and Grade 4 KOA
Concomitant skin disease at the application site.
Significant injury to the knee within the previous 6 months or a rash or open wound over the knee.
Patients with any intercurrent disease or condition that may interfere with the free use and evaluation of the affected knee and may predispose them to a high probability of interfering with the follow up (Neurological problems, Severe Congenital Defects, Peptic Ulcer, Severe Liver Diseases, Severe Coronary Diseases, Renal Diseases, Active Psychiatric Disorders, or other clinically significant conditions).
Patients who will be unwilling to participate in the study. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.KOOS Index
2.VAS
3.Active Range of Motion (AROM)
4.Eight-meter walk test |
On Day 7,14,28 and 35 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
On Day 7,14,28 and 35 |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Osteoarthritis is the most common type of arthritis, with the knee being the most frequently affected large joint. It is marked by focal cartilage loss, subchondral bone sclerosis, and the formation of osteophytes. Knee Osteoarthritis (KOA) is a major cause of painful walking and is more common in females. It affects around 250 million people worldwide and has a prevalence of 22% to 39% in India. KOA can be primary or secondary, with early signs including joint space narrowing, best seen in weight-bearing X-rays. Osteophytes are the hallmark, and other changes include subchondral cysts, deformities, loose bodies, and calcifications. CT, ultrasound, and MRI can help in diagnosis. The main goal of treatment is pain relief and slowing disease progression, as the condition is incurable. Analgesics and anti-inflammatory drugs are first-line treatments but have potential side effects such as gastrointestinal, cardiovascular, and renal complications. In the Unani system of medicine, KOA is included under the general term Waja al Mafasil, which covers all types of arthritis. Waja al Rukba refers to knee pain. Unani treatment is based on the principles described for Waja al Mafasil and includes three approaches: Ilaj bil Tadbir wa Taghzia, Ilaj bil Dawa, and Ilaj bil Yad. Among non-pharmacological methods, Dalk (massage) is an important regimen for musculoskeletal and other disorders. Dalk Layyin with Ravghan i Qust is mentioned for treating Waja al Mafasil, but its efficacy and safety have not been scientifically validated. This study is planned to evaluate its role in managing KOA. |